MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CA 19-9; NIG SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR PANCREATIC CANCER

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of elevated advia centaur ca 19-9 results for two patients when using lot 535 which were discordant relative to repeat testing when using reagent lot 537 and an alternate method.The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is evaluating this issue.
Event or Problem Description
The customer reports observation of elevated advia centaur ca 19-9 results for two patients when using lot 535 which were discordant relative to repeat testing when using reagent lot 537 and an alternate method.Initial elevated advia centaur ca 19-9 results (above reference range) were obtained for two patient samples.These results were reported to the physician(s), who questioned the results.The patient 1 sample was repeated on the same advia centaur instrument using reagent lot 537 and the patient 2 sample was repeated using an alternate method producing lower results.The lower results were considered correct, as they were in agreement with the clinical picture, and corrected reports were issued based on the repeat testing.It is unknown whether the affected patients have been diagnosed with cancer.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A customer from outside the united states reported observation of an elevated advia centaur ca 19-9 result which was discordant relative to repeat testing., siemens investigation confirmed an average positive bias of 56.4% with a sample population from the asia pacific region and atellica im and advia centaur 19-9 assay kit lots ending in 535 as compared to previous lots.However, investigation did not confirm the complaint allegations of commercial quality control results outside of range.Urgent medical device correction (umdc) aimc 24-14.A.Us and urgent field safety notice (ufsn) aimc 24-14.A.Ous will be distributed to customers who have received the affected product to notify them of the bias.The communication will advise customers to discontinue use of the affected product.Note: in section, codes for investigation findings and investigation conclusions were updated.

• Brand Name: ADVIA CENTAUR CA 19-9
• Common Device Name: NIG SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR PANCREATIC CANCER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; registration #1219913; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19554955
• Report Number: 1219913-2024-00351
• Device Sequence Number: 17346339
• Product Code: NIG
• UDI-Device Identifier: 00630414574028
• UDI-Public: 00630414574028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K031393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10491244
• Device Lot Number: 535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1219913-07-18-2024-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown